Panama Jack

Product NDC
58443-0452
Requested package NDC
58443-0452-9
11-digit product format
584430452
Labeler code
58443
Product ID
58443-0452_d2080b57-b80e-4f23-e053-2995a90ad852
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-05-22
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength
29 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0452-9584430452093785 mL in 1 BOTTLE (58443-0452-9) 3785 ml2019-05-220000-00-00NoNoCurrent